A multicentre, dose finding, phase II Study of CP-4055 in combination with Sorafenib in patients with metastatic malignant melanoma
Conditions
Interventions
Product Name: CP-4055 for infusion
Product Code: CP-4055
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Nexavar tablets 200mg
Pharmaceutical Form: Tablet
Sponsors
Clavis Pharma ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed stage IV or unresectable stage III non-ocular malignant melanoma who have or have not undergone prior bio- and/or chemotherapy for treatment of melanoma 2. Measurable disease according to Response Criteria for Solid Tumors (RECIST) 3. Performance Status 0 – 1 according to ECOG (Eastern Cooperative Oncology Group) Performance Status 4. Age 18 years or more 5. Life expectancy > 3 months 6. Signed informed consent 7. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. 8. Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose 9. Adequate haematological and biological functions: • Bone marrow function: a. Neutrophils above or equal to 1.5 x 109/L b. Platelets above or equal to 100 x 109/L c. Hb above or equal to 10 g/dL • Hepatic function: a. AST/ALT less than or equal to 2.5 times institutional upper limit of normal (ULN). If liver metastases, less than or equal to 5 times institutional ULN b. Serum bilirubin and alkaline phosphatase less than or equal to 1.5 times institutional ULN • Renal function: Creatinine less than or equal to 1.5 times institutional ULN Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known brain metastases 2. Diagnosis of ocular malignant melanoma 3. Radiotherapy to more than 30 % of bone marrow 4. Participation in another therapeutic Clinical Study within 30 days of enrolment or during this Clinical Study 5. Requirement of concomitant treatment with a non-permitted medication: • Alternative drugs • High doses of vitamins • Antikoagulant medication, i.e. Marevan, Coumarin, Jantovan, and Waran (warfarin) 6. History of allergic reactions to Ara-C or egg 7. History of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib 8.Presence of any serious concomitant systemic disorders incompatible with the Clinical Study (e.g. uncontrolled inter-current illness including ongoing or active infection) 9. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance 10. Pregnancy, breastfeeding or absence of adequate contraception for both male and female fertile patients 11. Known positive status for HIV and/or hepatitis B or C 12. Drug and/or alcohol abuse 13. Any reason why, in the Investigator’s opinion, the patient should not participate 14. Prior treatment with CP-4055 and/or sorafenib 15. Significant history of cardiac disease, including any of the following: •Uncontrolled hypertension •Unstable angina pectoris •Congestive heart failure •Myocardial infarction within the past 6 months •Unstable ventricular arrhythmia •Other cardiac arrhythmia 16. Condition that impairs ability to swallow pills 17. Tendency of bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the - Time to progression - Duration of tumour response - Safety and tolerability of the treatment ;Primary end point(s): Tumour response defined as Complete Response (CR) and/or Partial Response (PR), characterized by measuring the target lesions, and according to the RECIST criteria. The Response Rate (= PR + CR) will be estimated and a 95 % confidence interval calculated. ;Main Objective: To evaluate the objective tumour response in patients with metastatic malignt melanoma when treated with CP-4055 for infusion D1-5/4w in combination with sorafenib | — |
Countries
Sweden
Outcome results
None listed